MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM

Model Number	02.07.0410SCF
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	08/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 september 2018: lot 122367: 25 items manufactured and released on 19 december 2012.Expiration date: 2017-08-31 no anomalies found related to the problem.To date, 20 items of the same lot have been already sold without any similar reported event.Other implant initially suspected to be loose, but not confirmed during revision so not explanted: gmk-revision 02.07.0684l revision fixed tibial tray cemented size 4 l (k123721), lot 122880: 40 items manufactured and released on 24 october 2012.Expiration date: 2017-09-30.No anomalies found related to the problem.To date, 38 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
On (b)(6) 2018 we were informed that the surgeon was revising the patient on (b)(6) 2108 due to suspected tibial loosening about 3 years and 5 months after primary.The surgeon revised the patient on the planned date but the loosening was not confirmed, so the reason for revision was generic pain and the surgeon revised the joint implanting a new insert semiconstrained 12mm s4.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM
• Common Device Name: TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7876587
• Report Number: 3005180920-2018-00688
• Device Sequence Number: 186790
• Product Code: JWH
• UDI-Device Identifier: 07630030817656
• UDI-Public: 07630030817656
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 02.07.0410SCF
• Device Lot Number: 122367
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention